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Rifaximin in Minimal Hepatic Encephalopathy

This study has been completed.
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center Identifier:
First received: September 20, 2007
Last updated: March 19, 2013
Last verified: March 2013
The purpose of this study is to determine whether alteration of gut flora with rifaximin can lead to improvement in driving performance, psychometric test performance, and quality of life in patients with minimal hepatic encephalopathy (MHE) and cirrhosis in a randomized, blinded, placebo-controlled trial.

Condition Intervention
Hepatic Encephalopathy Drug: Rifaximin Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Rifaximin on Driving Performance, Psychometric Test Performance and Quality of Life in Cirrhotic Patients With Minimal Hepatic Encephalopathy: Randomized, Double-blind, Placebo-controlled Trial.

Resource links provided by NLM:

Further study details as provided by Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center:

Primary Outcome Measures:
  • Driving performance [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Psychometric test performance [ Time Frame: 8 weeks ]
  • Quality of life [ Time Frame: 8 weeks ]

Enrollment: 42
Study Start Date: October 2007
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Will be given placebo and follow the exact procedures as the experimental section
Drug: placebo
same as the experimental arm
Experimental: Drug Drug: Rifaximin
550mg BID rifaximin for 8 weeks


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-65 years
  • Cirrhosis diagnosed on clinical grounds
  • MHE diagnosed by abnormalities in a psychometric battery (NCT-A, NCT-B, ICT BDT and DST impaired beyond 2 standard deviations of known control values on any of the above 3 tests will be considered to have MHE)
  • Current drivers (valid driving license and driving at least 20 miles/week)
  • All women of child-bearing potential will be required to use effective contraception

Exclusion Criteria:

  • Current or recent (< 6 month) use of alcohol (AUDIT questionnaire will be used; any cirrhotic with a value of > 0 will be excluded) and a positive blood alcohol level
  • Use of antibiotics within last 6 weeks
  • Allergy to rifaximin, rifabutin, rifampin, or rifapentine
  • Infection or gastrointestinal hemorrhage within the last 6 weeks
  • Renal insufficiency
  • Hepatocellular carcinoma
  • Psychoactive drug use, including interferon concurrently
  • Non-drivers and those who drive less than 20 miles/week
  • Pregnancy and breastfeeding
  • Excluding patients with OHE:

    • Detailed neurological examination to check for dysarthria, asterixis, ataxia and disorientation
    • Detailed history-taking from friends/relatives only after taking the patient's permission
    • Mini-mental status examination > 25
    • Episode of overt (clinical hepatic encephalopathy) within 6 months
    • Current treatment with lactulose, rifaximin, zinc, or metronidazole
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Please refer to this study by its identifier: NCT00533910

United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Valeant Pharmaceuticals International, Inc.
Principal Investigator: Jasmohan S Bajaj, MBBS, MD, MS Medical College of Wisconsin
  More Information

Responsible Party: Jasmohan Bajaj, Associate Professor of Medicine, Hunter Holmes Mcguire Veteran Affairs Medical Center Identifier: NCT00533910     History of Changes
Other Study ID Numbers: PRO00006863
Study First Received: September 20, 2007
Last Updated: March 19, 2013

Keywords provided by Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center:
Minimal hepatic encephalopathy

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents processed this record on September 19, 2017